1.Abstract

1.1.Aim: The objective is to report our experience with use of the “No Touch” method to reduce penile implant infections.

1.2.Materials: We carried out a retrospective, single-centre study, from January 2011 to December 2015 in 94 patients having undergone implantation of a total of 102 penile prostheses using the “No Touch” surgical technique. This procedure uses an additional non-adhesive, transparent surgical drape to avoid any contact between the penile implant and the patient’s skin. The patients included presented severe erectile dysfunction. We recorded: the characteristics and causes of the patients' erectile dysfunction, along with perioperative events: implant infections or revision surgery.

1.3.Results: The mean age was 61.8 years (standard deviation ±9.37) (extremes 29.1-81.8 years). Comorbidities included 57% patients with hypertension, 47% with dyslipidaemia, 33% with type-2 diabetes and 18% with treated ischaemic heart disease. 46% of patients were overweight, 20% were obese and 35% were smokers. Finally, 35% of patients had been treated for prostatic adenocarcinoma, either surgically or by radiotherapy. Postoperatively, there was a 2% infection rate following the first implantations and a total infection rate of 4% for all procedures (first implantation and repeated implantation).

1.4.Conclusion: In a population with risk factors for infection, the principles of the “No Touch” surgical technique are an effective additional therapeutic option to reduce penile prosthesis infections.

2.Introduction

Erectile dysfunction is a multifactorial condition and
it is estimated that 31.6% of men over the age of forty in France present
moderate erectile dysfunction (according to IIEF-5 score) [1]. With patient demand for management of their erectile dysfunction
growing and effective treatments becoming increasingly available in today’s
society, in which there is greater recognition of the sexuality of older
couples, it is becoming essential to offer therapeutic options. Surgical
treatment of erectile dysfunction via the implantation of a penile prosthesis
is recommended for patients in whom first and second-line medical treatments
have failed and/or those who are seeking a permanent solution to their problem [2]. Penile implants provide well-prepared couples with greater sexual
satisfaction than first-line treatments, with a satisfaction rate of around 91%[3,4]. The most feared complication of this surgery is penile implant
infection. When implant infection occurs, this usually requires hospitalization
of the patient, with further emergency surgery. Therefore, the question is
raised of how to reduce the risk of penile implant infection. An enhancement of
the surgical technique has been proposed in order to optimize the reduction of
the implant infection risk[5]. The “No Touch” surgical technique concept is based on the fact that it
is usually germs present on the patient’s skin that are implicated in penile
implant infections[6]. The skin acts as a bacterial reservoir in this case. The aim of the
“No Touch” technique is to avoid contact between the implant, the patient’s
skin, the surgical instruments and the surgeon’s gloves. Our objective is to
report our experience with use of the “No Touch” method in terms of its impact
on the reduction of penile implant infections.

3.Methods

This is a retrospective single-center study from
January 2011 to December 2015. The patients included presenting severe erectile
dysfunction, resistant to first and second-line treatments or refusing these
treatments for cost-related reasons or problems related to the acceptability of
oral or local treatments. The patients all underwent an interview and a standardized
physical examination before surgery. The data studied were derived from the
patients’ medical files and the following were collected for each: demographic
characteristics, comorbidities and causes of their erectile dysfunction. The
patients were all given a cooling-off period in which to consider their
decision of at least one month prior to surgery. Each procedure was performed
using the “No Touch” technique initially described by Dr J.F Eid[5], developed to reduce the risk of penile implant infection. The
procedure begins with a penoscrotal incision and dissection of the superficial
fascia before insertion of a Scott retractor. This is then covered with a
non-adhesive transparent drape. An opening is made in this drape and disposable
hooks are used to simultaneously retract the drape and the edges of the skin
incision. The skin, which is the main reservoir of germs, is thus totally
excluded from the surgical field. Throughout the procedure, there is no contact
between the patient’s skin, the surgeon’s gloves or the surgical instruments (Figure 1).

The rest of the procedure follows the same surgical
phases conventionally used for penile prosthesis implantation. Each patient was
seen again after seven days, six weeks, six months and one year, for an
interview and a standardized physical examination, including, in particular,
assessment of patient satisfaction, the cosmetic appearance, the scar condition
and the good mechanical function of the implant. The data were analyzed
retrospectively. The Chi2 test was used to analyze the independence of
qualitative factors (XLSTAT 2016, Addinsoft™).

4.Results

Ninety-four patients were included for the
implantation of 102 penile prostheses. The mean age of the patients was 62
years (± 9 years), with extreme ages of 29
and 82 years. Comorbidities included 57% hypertensive patients and 48% with
dyslipidaemia. 34% of patients had type-2 diabetes and 18% had treated
ischaemic heart disease. 44% of our patients were overweight based on the WHO
definition and 24% were obese. Finally, 34% of patients in our study were
active or former smokers, with more than 15 pack-years. In terms of urological
history, 35% of patients had been treated for prostatic adenocarcinoma, either
surgically or by radiotherapy. 21% had a history of
penis surgery and 9% of patients had concurrent Peyronie’s disease. 4% of
patients presented erectile dysfunction secondary to erect penis trauma.
Finally, 5% of patients had undergone kidney transplantation and 3% of patients
presented severe erectile dysfunction secondary to one or more episodes of
priapism. Only one patient had a history of extended rectal surgery to treat
adenocarcinoma of the colon (Table 1).

The type of implant (three-piece) used for surgery was
more often a Coloplast™prosthesis (51%) than an A.M.S™ prosthesis. Immediate
postoperative complications included one patient who underwent revision surgery
for a haematoma, and a 2% infection rate following first implantations. For
surgery to change a penile implant, there was an 11% infection rate (p value=0,02;
Chi 2 test) i.e. a total infection rate of 4% for all implantation procedures
combined (Table 2).

The bacteria found in penile implant infections - for
either first implantations or repeated implantations - included: Pseudomonas
aeruginosa for one patient, Escherichia Coli for another. One of our patients
presented a polymicrobial culture: Enterococcus faecalis ESBL (extended-spectrum
beta-lactamase), Prevotella
biviae. Finally,
no microorganism was detected for the last patient (culture probably eliminated
by antibiotic therapy).

During follow-up consultations, the patient
satisfaction rates after 3 months and 1 year were 89% and 80% respectively. Over the inclusion period and after one year of
follow-up, there were 4 revisions for non-septic problems, i.e. a rate of
4%. These revision surgeries were mainly related to problems of tubing position
or pump position.

5.Discussion

In this series, the risk factors for penile
dysfunction are those classically described and found in the literature [2,7,8], although hypertension is the most represented risk factor among our
patients. In addition to endothelial and neurotoxic causes of erectile
dysfunction, we also find traumatic damage; but treatment of prostatic
adenocarcinoma, either surgically or by radiotherapy, is the most frequent
cause in our study. However, the therapeutic procedure alone is not responsible
for the erectile dysfunction; its combination with medical risk factors also
plays a role. The most feared complication of penile implant surgery is implant
infection, since this requires emergency surgery and has serious physical and
psychological consequences for the patient. In addition, implant infection
implies a high cost to health care payers, due to its complex multimodal
management. This cost is estimated to be six times higher than the cost of the initial
surgery[9,10]. In this series, complying with the principles of the “No Touch”
surgical technique, the implant infection rate is 2% in first implantations. In
the literature, this rate ranges from 0.1 to 7% in experienced teams following
first implantations and from 0 to 33% following repeated prosthesis
implantations (revision surgery)[11]. The author of the original surgical technique reports an infection
rate of 0.5%[12]. However, it is difficult to compare infection rates between studies
due to the significant variability in surgical procedures used, as well as in
perioperative antibiotic usages and the characteristics of the populations
studied.

The population in this study presents surgical site
infection risk factors that may partially explain our infection rate. 66% of
our patients have a BMI of over 25 kg/m2
and a third of our patients have type-2 diabetes. Although type-2 diabetes has
clearly been identified as an implant infection risk factor (particularly in
the study by Mulcahy concerning more than 6000 cases)[13], this is still subject to debate[14]. With respect to overweight and obese patients, we cannot reach a
conclusion due to the small population size and its frequent association with
type-2 diabetes. However, it has now been demonstrated that adipose tissue
actively contributes to inflammation and plays a role in immunity via the
production of anti-inflammatory factors such as leptin and adiponectin[15]. This has led some authors to suggest that obese people may be more
prone to the development of surgical site infections[16,17]. As concerns our bacteriological results on infected implants, we did
not find any staphylococcal infection. This confirms that the use of coated
implants and the “No Touch” technique helps combat commensal skin bacteria and
totally isolate it from the surgical field. Finally, our bacteriological
results also show an evolution in the flora responsible for implant infections
towards more virulent microorganisms[6,11,18]. The “No Touch” method therefore constitutes one of the options
available to combat implant infections. From a medico-economic point of view,
the additional cost of the method is very moderate compared to the cost of
hospitalization and surgery for implant infection. The “No Touch” method
requires the use of a Scott retractor with disposable hooks, as well as a
transparent surgical drape. The surgery duration is only slightly longer and
does not therefore lead to any additional costs related to operating theatre
use. If this small additional cost reduces surgical site infections, this
avoids the costs of implant infection to health care payers, represented by
hospitalization for several days, prolonged intravenous antibiotic therapy,
prolonged local treatments and revision surgery.

6.Conclusion

Erectile dysfunction is an increasingly frequent
reason for urology and andrology consultations. While age is an independent
risk factor for erectile dysfunction, the condition is multifactorial and
cardiovascular diseases, smoking, metabolic syndrome with their endothelial and
neurotoxic disorders are the main causes. When first and second-line treatments
are inadequate or abandoned, penile implants are effective for restoring sexual
satisfaction within couples seeking this treatment. An improvement in the
quality of life of the couple is observed. However, the most serious
complication is infection at the surgical site. The principle of the surgical
technique for penile prosthesis implantation: “No Touch” offers the advantage
of a low additional cost and avoids any contact between the implant and the
patient’s skin, a genuine reservoir of bacteria. Thanks to the extension of
this technique - or, in any case, of its principles - aimed at reducing contact
between the patient’s skin and the implant, in patients who have been better
prepared in the operating theatre, with experienced surgeons using the
latest-generation coated implants, the implant infection rate has fallen
significantly. This surgical solution has thus become a safe and effective
therapeutic option.

Figure 1: The incision is covered with a non-adhesive transparent drape.

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